Director Clinical Operations

Hobson Prior are looking for a Director Clinical Operations to join a fantastic pharmaceutical organisation on a permanent basis with the ability to work remotely. Our client is focused on distributing essential medicines to patients.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- You will be ensuring the completion of all study-related materials and systems according to timelines and standards.
- In this role, you will be responsible for contributing to the development of team and resource planning.
- Responsible for supporting program management with supportable and clear timeline projections and reprojections.
- For this role, you will be responsible for one or more studies, depending on complexity. Leading across regions/countries to execute trials within Gastroenterology.
- Responsible for oversight of study budget, investigator and vendor contracts, budgets, and payments; completes accruals on a regular basis.
- Responsible for development and review of protocols, investigator brochures, data outputs, clinical study reports and other applicable documents.
- Leads the clinical operations team (CTMs, CRAs, and CTAs) and cross-functional clinical trial team in the planning, execution, and completion of clinical trials - ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines.
- Contributes expertise in all operational activities relating to the execution of clinical trials.
- Interacts and develops relationships with key opinion leaders, potential/selected investigators, and other key experts through attendance at therapeutic conferences and study investigator meetings.
- Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors.
- Provides input on the development of eCRF design.
- Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalated study-related issues, risks, and mitigation plans to management in a timely manner.
- Oversees recruitment plans and activities to meet study enrolment goals and timelines.
- Any other assigned duties.

**Key Skills**:

- Interpersonal versatility, able to simultaneously serve as an individual contributor and a leader.
- Excellent people management and leadership skills, inspiring and motivating talent.

**Requirements**:

- At least 16+ years of related and progressive clinical trial management experience required.
- Expertise in full-cycle drug development.
- Advanced understanding of clinical trials (processes, protocols, and medical terminology).
- Advanced experience utilizing CTMS, EDC, TMF and related software.
- Extensive experience in management and monitoring of CRO and investigative sites.
- Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management.
- Active contributor to vendor governance process.
- Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research and development regulations.
- Motivated to work in a fast-paced, high accountability environment.
- Strong experience supporting department initiatives.
- Experienced leader working in dynamic cross-functional team environment; ability to influence cross-functionally to achieve business objectives both internally and across organisations.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.